Vietnam MOH registration 240000031/PCBA-HCM

IVD is a hollow bottle used in the working process

VN: IVD là chai rỗng dùng trong quy trình làm việc

Vietnam·Risk Class TTBYT Loại A·cobas® prime User Workflow Reagent Bottle·Roche Molecular Systems, Inc.·Registered Jan 04, 2024

Registration details

Analysis ID: 240000031/PCBA-HCM
Submission ID: 000.00.19.H29-231229-0009
Product Type: cobas® prime User Workflow Reagent Bottle
Product Code: 08460426190

Company information

Manufacturer: Roche Molecular Systems, Inc.
Manufacturer Country: UNITED STATES
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: cobas® prime User Workflow Reagent Bottle is used with the cobas® prime pre-analytical system.

Dates and status

Registration Date: Jan 04, 2024

About this record

Access comprehensive regulatory information for IVD is a hollow bottle used in the working process in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000031/PCBA-HCM and manufactured by Roche Molecular Systems, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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